The following data is part of a premarket notification filed by Merit Medical Systems, Inc with the FDA for Preludesync Distal Radial Compression System.
| Device ID | K180723 |
| 510k Number | K180723 |
| Device Name: | PreludeSYNC DISTAL Radial Compression System |
| Classification | Clamp, Vascular |
| Applicant | Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | Susan Christensen |
| Correspondent | Susan Christensen Merit Medical Systems, Inc 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-19 |
| Decision Date | 2018-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450400443 | K180723 | 000 |
| 20884450567870 | K180723 | 000 |
| 20884450525214 | K180723 | 000 |
| 20884450525573 | K180723 | 000 |
| 20884450462946 | K180723 | 000 |
| 10884450445201 | K180723 | 000 |
| 20884450411197 | K180723 | 000 |
| 20884450411517 | K180723 | 000 |
| 20884450411494 | K180723 | 000 |
| 20884450567818 | K180723 | 000 |